Tuesday, October 30, 2007

Skirting CME Regulations in Real Time: Watch it Here!

Because the Senate Finance Committee concluded that the commercially-funded CME system is broken, the ACCME issued new policies intended to create thicker firewalls between industry and medical education. In a prior post, I "translated" these new policies into language mere mortals can understand. Now, in a new articlein Medical Marketing and Media, we can see how commercial sponsors are already finding ways to avoid real changes.

The article profiles Bruce Bellande, Ph.D., president of CME Enterprise. Dr. Bellande bemoans that he and his parent organization, Deborah Wood Associates, have to demonstrate that they are meaningfully "separate." Deborah Wood Associates began as a medical education communication company, but has expanded into a 100-employee strong marketing consultation firm for the pharmaceutical industry. In order to show ACCME that CME Enterprise is now separate from Deborah Wood Associates, Bellande moved his staff into "new quarters" (read: Time for everyone to pick up your laptops and move down the hall!) and he had to create a trail of paperwork proving that a firewall exists. This included an organizational chart, some disclosure forms, and a few other documents that he likely had on his computer because ACCME has always required these for accreditation. He fired it off to Murray Kopelow, CEO of ACCME, and received this letter back, saying, essentially, that the firewall requirements were satisfied.

If you go right now to the Deborah Wood Associates website, you can see just how strict ACCME's new firewall policies are. This site is geared toward pharmaceutical companies wanting to sell their products, and their techniques couldn't be clearer: "See how we achieve optimal results through two dedicated groups: CME Enterprise and Avant Healthcare Marketing."

This rice paper firewall makes a mockery of ACCME's new policies. It's astonishing that Kopelow has signed off on CME Enterprise.

13 comments:

TM, MD
said...

Yes, very discouraging. Can you recommend a reasonable number of CME providers (ie reasonable to regularly consume in a limited period of time)that are not pharma-supported? In addition to your newsletter that it, which I already get.

Dear Ipsedixitier: Here's the real deal with Nemeroff and money and who cares and who doesn't—as straight as it gets—from someone who's watched him suffer through hard times—and has heard him talk about his professional world in complete confidence...when no one else was around to applaud, or light his cigar, or put another red cent into his pocket.

And I have little doubt you will dismiss what I say as hero worship or butt-kissing or whatnot. But these two-line quips, like yours, which may be permissible in the rough-and-tumble realm of blogging—are just part and parcel of so many things going wrong in psychiatry right now. So, forgive my tantrum in advance.

In the 1960s and '70s, there was widespread debate about whether psychiatry would survive as a branch of medicine into the next century. Soon after, psychiatry and science collided in a big way, and today we know that psychiatric medicine is very much here to stay. No real argument there.

Ironically, by 2007, psychiatric research has surpassed many other medical fields in its breath, complexity, and treatment successes; and as an historical witness to this (r)evolution, I am very proud to know some of the men and women who were instrumental in putting the brain sciences on the map to stay.

But I am also a little wary. And I have good reason to be. Why? because I hang out with some of the lecture-circuit psychiatrists—the very people that some of you send your patients to for $500 consults—so I know first-hand why some of you are so resentful toward this rather small group. Even though you'll receive a confident diagnosis and a succinct smattering of advice for your patient's $500, it is hard to ignore the often profound disconnect between psychopharmacology and real-world psychiatry...yes, the real-world psychiatry that those "has beens" of forty years ago were trying to tease out of some really sick people in order to get them to a better place. Could they have succeeded in healing at the same level that YOU can today with a dozen billion-dollar drugs at your disposal? probably not. But that's another story for another time.

Where ipsedixiter errs, I submit respectfully, is that he thinks a guy like Nemeroff, whose name has been attached to more of those mega-drugs than almost anyone, is not a "real" psychiatrist, but some sort of hired mouthpiece. That he's traded his soul for a golden parachute; his conscious for a big-ass wallet.

Nemeroff might be the Teddy Roosevelt of psychiatry, which is why his very name illicits such passion on both sides of the aisle. Maybe he has gone a little too far at times to accommodate "industry." And, perhaps—as my first wife reminded me both often and forcefully—I should put a lid on it and let him fend for himself doggoneit AND PAY MORE ATTENTION TO ME. Or we could go really deep and opine that I am suffering the ultimate psychic battle between my Jewish side (ie, loyalty) and my Italian side (ie, F...ING loyalty).

But.

But if you or your child or a friend or even that numbnut of a President we have were driving through Atlanta and something really bad happened in the car and you had to find a hospital real fast and you screeched off the highway, you'd be really lucky to find yourself in Charlie's office. It wouldn't matter whether he was talking to the CEO of BMS, or yelling at me on the phone for one thing or another, or was wedged under the couch looking for his lighter, he'd be outta that office in a heartbeat, doing what needed to be done to help, because that's what someone who cares and loves what he's doing does when the chips are down.

If you spent any time at all with him, you'd realize that Nemeroff is one of the most insightful psychiatrists around—which might be why he packs them in to the lecture halls. That's something you can't put on a disclosure statement Ipsedixter. And that's why Charles B. Nemeroff will be on Bulletin's editorial board for as long as he damn well pleases. If that bodes poorly for us, so be it.

Interesting and passionate discussion re: Nemeroff. I'm sure most anyone would help another person if injured. I am still interested in conflict of interest.That's an ethical question, and one that needs answering without regard to cigars, or first aid, good natured conference halls or stacked board rooms.

Does conflict of interest matter? owning the patent on the Li patch, and all of the other stuff written here and at CL Psych blog---well,I'm asking as a patient/consumer/mother, what exactly is right here?

Do we have an ethical obligation/conflict of interest problem or not??-Damn leave the personal defense of the person out of it.

That has nothing to do with the conflict that needs addressing, and really if these blogs were not here, Charlie wouldn't have anyone telling us he can't find his lighter.

Trying to make sense of the ethical obligation/conflict of interest problem is the very heart of the matter, as you say, and a lot of us have burned through cheap keyboards trying to make sense of it.

And you're right of course—Charlie Nemeroff doesn't get us to a place where we can parcel out the pros and cons of industry sponsored science with any more success. But the lack of specificity when it comes to accusing Nemeroff of industry misdeeds is epidemic; so if I responded personally, which, admittedly, I did, it's because I resent that he has become some sort of "SUPER NOUN" for ethically muddled matters. I don't believe that. And I don't like it because it doesn't get us any closer to consensus. This is not an issue that needs more fire under the pot.

In the most simplistic of terms, it seems to me that when a medical matter (better term escapes me here) is ethically compromised, it results in (1) patients being prescribed one agent over another for no solid reason, (2) that the new drug is not more efficacious than existing drugs, (3) that the new prescription is probably more expensive than a comparable agent, and, most importantly, resulting in (4) the patient's quality of life is not improved.

We'd all agree that a researcher involved in fictionalizing post-marketing surveillance to the detriment of patient mortality or morbidity might as well ride away into the sunset straight to the Brooklyn House of Detention. That rare case aside, how can physicians keep an open mind to new research and new drugs while not being unduly influenced (ie.,seduced) by all the freebies that come with it?

I’m sorry to sound like a broken record, but I am 100% in agreement w/ Danny Carlat here: It comes down to CME. If you take the enormous profit out of CME and re-direct it to what it was meant for, medicine can re-take the high ground again. In the interest of time, I am going to copy a section of something I wrote about CME on 15 September, 2007. It might not be that smart—but it does begin to change the entire equation—which is what’s needed when something has rotted to the core. Here goes...

Now that many of the problems have been noted, perhaps it is time for your readers to undertake a vigorous debate on how they would change CME it was up to them?

For whatever it's worth, here are my two cents worth: For decades now, people a lot smarter than I am have built this (CME) thing into a behemoth of complexity. Everyone has a different take on it. GSK will sponsor something that Pfizer won't, and vice versa. There is even profound disagreement in the U.S. Senate. So, I would tear the whole thing up and focus on the group of people that all of these regulations are supposed to help: Physicians.

First, merge Category 1 and Category 2 CME. Period! There's no need for both. If society cannot trust physicians to abide by the honor system, than we have bigger problems than medical education can cure. When you read a journal or attend a symposia, put the pretest, posttest and answer key in a file in your office. If you're audited you have the proof that you have been continuing your education. The medical community is a much better over-seer than the ACCME. As an MD, if you don't keep up with new science, patients—some of whom walk and talk like doctors as it is—will flush that out and make your life miserable. God forbid if you are litigated against. The amount of continuing education, or lack thereof, can come into play in court. So, it is in your personal, professional, and, perhaps, legal interest to get together with colleagues at meetings to hash things over. Enforcement becomes moot.

My second change would be that only teaching institutions can offer CME. The private medical education companies can still set-up the program, but it must pass muster from the university. Remember that all of the test grading, etc., the university would normally do has been waived, since the physician is now keeping her own records. So, the university is saving money which can be passed on to the end-user. The ACCME can monitor the universities if they so choose, and—most importantly—standardize fees. Yes, BMS should pay a larger fee for putting on a program than should a small association or patient advocacy group. But the fee should be on a standardized, sliding scale that is universal throughout the University CME system. The end result is that the doctor gets the CME for free. That should be axiomatic—no matter who sponsors the program.

Three (3) CME-Accredited articles were added to the Psychopharmacology Bulletin Journal CME Index on Medscape/WebMD earlier this morning. They are COMPLETELY INDUSTRY FREE in both placement and content. Good reading...

Seehttp://www.medscape.com/index/list_3091_0

* CME How Long Do Psychiatrists Wait for Response Before TheySwitch to Another Antipsychotic? There is little evidence to helpphysicians decide when to change antipsychotic medications inschizophrenia. The current study examines common practices amongpsychiatrists.Psychopharmacology Bulletin, November 2007http://www.medscape.com/viewprogram/8115

* CME Do Antipsychotic Drugs Influence Suicidal Behavior inSchizophrenia? Antipsychotics can have a negative, null or positiveeffect on suicidality in schizophrenic patients. Whether and how antipsychotics affect suicidal behavior is reviewed in light ofrelevant research.Psychopharmacology Bulletin, November 2007http://www.medscape.com/viewprogram/8116

* CME Concordance With Treatment Guidelines for BipolarDisorder: Data From the Systematic Treatment Enhancement Programfor Bipolar Disorder Concordance with treatment guidelines forpsychiatric illness is generally poor. The current study examinesmedication and dose concordance after training in evidence-basedcare for bipolar disorder.Psychopharmacology Bulletin, November 2007http://www.medscape.com/viewprogram/8117

James, thanks for the reply and the information you left in the comments. I appreciate the honesty here, and wrote a post on my own blog. You know we could pick on Joe Biederman too. All in the name of transparent and honest industry based paradigm called "psychiatry". I am not anti-psychiatry by the way--just a savvy consumer.

Thanks for the kind words, Stephany. Psychiatry is not the sleepy little field it once was, but a discipline chock full of big money players and brilliant minds. That's great in so many ways for so many patients, but it has its price(s). Like Faulkner said, we endure.